Gilead gets green light for remdesivir use for Covid-19 in Japan
The drugmaker got the nod just three days after making the application with Japan citing ‘exceptional circumstances’ for the rapid approval
Tokyo— Japan approved the antiviral drug remdesivir for use against the novel coronavirus on Thursday, three days after receiving an application from Gilead Sciences, the company said in a statement.
The rapid move by Japan’s usually conservative authorities comes days after the US authorised the drug for emergency use on Covid-19 patients. The special approval process used in Japan is reserved for urgent situations, where there is no alternative, and the drug has already been authorised for use overseas.
Finding a treatment for Covid-19 could move the world closer to easing lockdown measures put in place to help slow its spread. One early analysis showed that about two-thirds of severe Covid-19 cases improved when treated with the drug, according to a report published in April.
Multiple trials of remdesivir are still underway. In April, the World Health Organisation (WHO) prematurely published results of a China trial by accident but retracted it soon after. The WHO post indicated that the drug didn’t show benefits in preventing death and reducing viral load, but the Chinese trial was halted early after researchers struggled to enrol patients.
“The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic,” Gilead chief medical officer Merdad Parsey said in the statement.
Gilead shares rose 0.6% to $77.95 at 11.50am in New York.
While the virus has so far wreaked less health damage in Japan than the US or some European countries, the economy has taken a severe hit. Prime Minister Abe Shinzo has said treatments and vaccines are needed to help restore economic and social activities.
Typically, for a drug to be approved in Japan, the government requires clinical trials to include Japanese patients, or for a new trial to be done in Japan, said Bloomberg Intelligence analyst Caroline Stewart, who covers the pharmaceutical industry. While doubt remains over its efficacy, “it’s better than nothing”, she added.
Abe had earlier flagged that the authorisation was expected on Thursday. Health minister Katsunobu Kato had said earlier in the week that the panel charged with deciding on remdesivir’s approval was to meet on Thursday and that the process would be completed as soon as possible.
Earlier this month, Japan’s health ministry said in a message to local governments that even if remdesivir is approved, supplies may be limited and will be controlled by the central government.
More than 15,000 people have been confirmed as infected with the virus in Japan, and more than 550 have died, although experts say the relatively small number of tests conducted means there are probably more undetected cases.
Japan has extended its nationwide state of emergency until May 31, with Abe saying the country’s coronavirus measures need more time to reduce infection rates. The state of emergency allows local governments to direct businesses to close and to urge residents to stay in their homes.
Abe said on Monday that he’s aiming to have Avigan, a drug that contains antiviral favipiravir, developed by Fujifilm Holdings, approved for use as a Covid-19 treatment by the end of May. He added in a live-streamed internet interview late on Wednesday that trials are also beginning with an anti-parasite drug known as ivermectin, developed by Nobel prize-laureate Satoshi Omura.
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